Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.

Inclusion Criteria:

• age > 1 year
• >90% of total calories via G-tube for > 6 months
• G-tube diameter ≥ 14 French
• moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score > 2
• anticipated stable GI-related medications for the duration of the study.

Exclusion Criteria:

• cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
• untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
• Nissen fundoplication
• use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
• allergy or intolerance to any component of the study diet
• inability to tolerate bolus gastric feeds.